MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported event was confirmed by evaluating the returned device.Visual inspection of the liner identified the damages on the locking feature as well as scallops.There were scratches on the rim of the liner.These damages were likely caused during an attempt to seat the liner into the shell and during removal.Dimensional analysis cannot be performed on the liner due to its impaction and resulting damage.Review of the device history record identified no deviations or anomalies would contribute to reported event.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the liner did not seat into the shell as required during an unknown surgery.The liner was removed and replaced with a second device for completion.No further event information available at the time of this report.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8416104
• MDR Text Key: 138815974
• Report Number: 0001825034-2019-01180
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000741
• Device Lot Number: 6394607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1